Vertos Mild - Post Market Patient Outcomes

This study has been completed.
Sponsor:
Collaborator:
Vertos Medical, Inc.
Information provided by (Responsible Party):
The Center for Pain Relief, Inc.
ClinicalTrials.gov Identifier:
NCT01076244
First received: February 24, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.


Condition Intervention
Lumbar Spinal Stenosis
Procedure: Minimally Invasive Lumbar Decompression

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.

Resource links provided by NLM:


Further study details as provided by The Center for Pain Relief, Inc.:

Primary Outcome Measures:
  • Pain as Measured by Visual Analog Scale (VAS). [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.


Secondary Outcome Measures:
  • Improvement in Functional Mobility [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.

  • Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ). [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]
    As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.

  • Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ). [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]
    For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.


Enrollment: 46
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Minimally invasive lumbar decompression Procedure: Minimally Invasive Lumbar Decompression
This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.

Detailed Description:

Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
  • Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
  • Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
  • Central canal cross sectional area clearly reduced per MRI/CT report
  • If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
  • Able to walk at least 10 feet unaided before being limited by pain
  • Available to complete 26 weeks of follow up
  • A signed Consent Form is obtained from the patient
  • Adults 18 years of age or older

Exclusion Criteria:

  • Prior surgery at the intended treatment level
  • Compound fracture with intraspinal retropulsion contributing to spinal stenosis
  • Disabling back or leg pain from causes other than lumbar spinal stenosis
  • Disc protrusion or osteophyte formation severe enough to confound study outcome
  • Facet hypertrophy severe enough to confound study outcome
  • Bleeding disorders and/or current use of anti-coagulants
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
  • Epidural steroids with 3 weeks prior to procedure
  • Inability of patient to lie prone for any reason with anesthesia support
  • Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
  • Dementia and/or inability to give informed consent
  • Pregnant and/or breastfeeding
  • On workman's Compensation or considering litigation associated with back pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076244

Locations
United States, West Virginia
The Center for Pain Relief, Inc
Charleston, West Virginia, United States, 25301
The Center for Pain Relief, Inc.
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
The Center for Pain Relief, Inc.
Vertos Medical, Inc.
Investigators
Principal Investigator: Timothy R Deer, MD Center for Pain Relief, Inc
  More Information

No publications provided

Responsible Party: The Center for Pain Relief, Inc.
ClinicalTrials.gov Identifier: NCT01076244     History of Changes
Obsolete Identifiers: NCT01130350
Other Study ID Numbers: #D1
Study First Received: February 24, 2010
Results First Received: February 22, 2013
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on October 30, 2014